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Product Name: Heavy Calcium Carbonate, Pharmaceutical Excipient Grade
Chemical Formula: CaCO3
Synonyms: Limestone, Calcite, Marble Powder
CAS Number: 471-34-1
EC Number: 207-439-9
Manufacturer Contact: Emergency phone numbers and office addresses found on original packaging and shipping documents
Recommended Use: Filler and diluent for pharmaceuticals, ingredients in oral solid dosage forms
Restrictions: Non-food applications beyond specified grade
Classification: Not classified as hazardous under GHS or OSHA criteria for this grade
Health Hazards: Repeated or prolonged inhalation of fine dust can irritate respiratory system; potential nuisance particulate; no acute toxicity expected in relevant applications
Environmental Hazards: Not expected to cause harm in aquatic environments under normal handling
Label Elements: No standard hazard pictograms required. Safety instructions recommended for dust avoidance
Other Hazards: Dust can aggravate pre-existing lung conditions. Always minimize airborne concentrations in processing and handling areas
Chemical Name: Calcium Carbonate
Concentration: More than 98% pure
Impurities: Trace amounts of magnesium carbonate, silica, and alumina possible based on mineral source; meeting pharmaceutical excipient standards
Additives: Contains no preservatives, colors, or other excipients
Grade: Suitable for pharmaceutical use — conforms to relevant pharmacopoeial specifications (USP, Ph. Eur, JP)
Inhalation: Move person to fresh air, seek medical attention if cough, shortness of breath, or discomfort persists; avoid forceful breathing
Eye Contact: Rinse immediately with plenty of clean water for several minutes, remove contact lenses if present, consult physician if irritation continues
Skin Contact: Wash thoroughly with soap and water, remove contaminated clothing; persistent irritation deserves medical attention
Ingestion: No expected toxicity by ingestion in pharmaceutical applications; if large amounts ingested seek advice from medical professional; rinse mouth
Flammability: Not flammable, not explosive, not supporting combustion
Suitable Extinguishing Media: Product does not burn; use media suitable for surrounding materials (water spray, dry powder, or CO2)
Protective Equipment: Firefighters should use respiratory equipment and full protective clothing if exposed to dust or decomposition fumes
Hazardous Combustion Products: No hazardous combustion products under normal conditions; decomposition releases only carbon dioxide at extremely high temperatures
Special Procedures: Isolate area if necessary due to potential dust
Personal Precautions: Avoid breathing dust, wear suitable respiratory and eye protection if dust forms
Environmental Precautions: Prevent material from entering sewers in large quantities. Spills on soil or drains have negligible impact under normal use
Cleanup Methods: Use industrial vacuum or wet sweeping to avoid airborne dust, collect in sealed container for disposal or re-use if uncontaminated
Emergency Procedures: Evacuate unnecessary personnel from area, ventilate zone with natural or mechanical means
Handling: Avoid generation of airborne dust, keep containers tightly closed, use only in well-ventilated areas. Do not eat, drink, or smoke in work area
Safe Practices: Wash hands after handling, avoid direct contact with eyes and prolonged skin exposure. Regular cleaning of workplace recommended
Storage Conditions: Store indoors in cool, dry, well-ventilated area. Protect from moisture and extreme temperatures. Containers should remain sealed when not in use
Incompatibilities: Strong acids (e.g., hydrochloric acid), produces carbon dioxide on contact
Occupational Exposure Limits: OSHA PEL for nuisance dust: total dust 15 mg/m³, respirable fraction 5 mg/m³; ACGIH TLV: 10 mg/m³ (inhalable), 3 mg/m³ (respirable)
Engineering Controls: Provide ventilation—local exhaust preferred for bulk handling operations. Keep dust levels below recommended limits
Respiratory Protection: Mask or respirator (N95 or better) for dusty conditions or where limits exceed
Eye Protection: Safety glasses with side shields or goggles where dust may contact eyes
Skin Protection: Gloves and protective clothing for sensitive skin. Wash hands thoroughly after use
Appearance: White, odorless, fine to granular powder
Odor: None
pH (aqueous suspension): 8.5–9.5
Melting Point: Decomposes at approximately 825°C
Solubility: Practically insoluble in water, dissolves in acids with effervescence
Boiling Point: Not applicable
Relative Density: About 2.7 g/cm³
Vapor Pressure: Not applicable
Partition Coefficient: Not relevant
Auto-Ignition Temperature: Not applicable
Explosive Properties: Not explosive
Other Data: Stable under normal conditions, can generate dust in mechanical conveying or mixing
Stability: Chemically stable at ambient temperature and pressure
Hazardous Reactions: Reacts with acids to produce carbon dioxide gas
Conditions to Avoid: Exposure to high humidity or acidic conditions
Incompatible Materials: Strong acids and ammonium salts
Decomposition Products: Carbon dioxide and calcium oxide at temperatures above 825°C
Acute Toxicity: Not acutely toxic by oral, dermal, or inhalation routes in typical handling concentrations
Irritation: May cause mild, transient irritation to eyes, skin, and respiratory tract if dust contacts mucous membranes or is inhaled
Chronic Effects: Chronic inhalation of excessive dust may affect lung function; compliant with pharmaceutical excipient standards to limit inhalable fraction
Carcinogenicity: Not listed as carcinogenic by IARC, NTP, OSHA, or ACGIH
Additional Information: No significant risk identified when used as intended in pharmaceutical formulations
Ecotoxicity: Product shows minimal toxicity to aquatic and terrestrial life. Large spills may affect water pH but effects dilute quickly
Persistence and Degradability: Inorganic substance; does not degrade biotically but remains stable and inert
Bioaccumulation: No potential for bioaccumulation
Mobility: Highly immobile in soil and water, remains as a particulate
Other Adverse Effects: Not expected to be hazardous under normal environmental exposure; industry practice includes good housekeeping to minimize dust in effluent water
Waste Disposal: Dispose of material as non-hazardous mineral waste unless contaminated. Observe all local, state, and national regulations
Recycling: If uncontaminated, re-use or recycle with other compatible mineral products
Container Disposal: Clean, empty packaging can be recycled or disposed of per municipal waste requirements
Special Considerations: Avoid dust release in landfill settings; do not dispose of in open drains or waterways
UN Number: Not regulated as dangerous goods for transport
Transport Hazard Class: Not classified under ADR, RID, IMDG, IATA
Packing Group: Not assigned
Proper Shipping Name: Calcium carbonate
Special Precautions: Protect from moisture and handling that may generate dust during transit
Safety, Health and Environmental Regulations: Product listed under major pharmacopeias. Exempt from TSCA, REACH registration for most uses. Not considered hazardous under US, EU, Japan workplace safety legislation
Labeling Requirements: Safety labeling for process dust and bulk handling; not classified under Globally Harmonized System
Other Regulation: Meets FDA GRAS status for intended use; compliance with GMP standards for pharmaceutical manufacturing
